Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133430

Enrollment

140

Registered

2014-05-08

Start date

2014-01-31

Completion date

2015-04-30

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

Postoperative delirium

Brief summary

The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

Detailed description

General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Interventions

DEVICEBispectral index, as measured by a BIS processor

Comparisons of incidence of postoperative delirium.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Patients age equal or more than 65 years. * Patients undergoing general anesthesia. * Patients undergoing scheduled, non-cardiac surgery

Exclusion criteria

* Patients undergoing neurosurgery. * Patients cannot understand Thai language. * Patients who have severe visual or hearing impairment.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients have postoperative delirium	Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.	Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.

Secondary

Measure	Time frame	Description
Number of patients with impaired cognitive function	Up to 6 months	Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .
Time to recovery	The end of surgery	Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.

Countries

Thailand

Contacts

Primary ContactDr. Yodying Punjasawadwong, MD

typunja@gmail.com+66819928082

Backup ContactDr. Tanyong Pipanmekaporn, MD

tanyong24@yahoo.com+66817648677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026